Portex 526060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10351688041128), received between Jan 25, 2023 and Jun 21, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Break; Break

  IT WAS REPORTED, THAT THE CANNULA BROKE INSIDE OF THE PATIENT. PARENTS USED TWEEZERS TO GET THE CANNULA OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171047 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244145 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244130 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244128 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244125 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244088 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244034 ↗
• InjuryJan 25, 2023Crack; Crack

  IT WAS REPORTED THAT THE CANNULA BEGINS TO CRACK AFTER 1-3 DAYS OF INSERTION AND NEEDS TO BE REPLACED. THE ISSUE TOOK PLACE IN THE PATIENT'S HOME. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT, AFTER TRACH REPLACEMENT TOOK PLACE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16244006 ↗